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The purpose of this study is to measure cerebral oxygenation and cardiac output of total shoulder replacement patients undergoing general anesthesia (GA) and positive-pressure ventilation (PPV).
We hypothesize that cerebral desaturation occurs frequently during GA with PPV, but is rare during GA and spontaneous ventilation. We also hypothesize that cardiac output usually is well maintained under GA in the sitting position when epinephrine is used, but that decreased cardiac output increases the risk of cerebral desaturation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Near-infrared spectroscopy | Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Casmed Fore-Sight Elite | Device |
| ||
| Non-invasive Cardiac Output Monitor (NICOM) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cerebral Desaturation Events | The number of Cerebral Desaturation Events (CDE) that occured. CDE is defined as a reduction in cerebral tissue oxygen saturation of >20% from baseline that lasts for 90 seconds or longer. | Day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Output (CO) | Cardiac output of patients as measured in liters per minute | Day of surgery |
| Cardiac Index (CI) | Average cardiac index for patients, a measurement of how efficient the heart is pumping. Measured in liters per minute per meters squared of heart size. |
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Inclusion Criteria:
Exclusion Criteria:
Patients younger than 18 years older and older than 99
Patients not intending to receive general anesthesia and peripheral nerve block
Indication for endotracheal tube
BMI ≥ 30
Ejection Fraction (if known) < 50%
Known significant restrictive or obstructive pulmonary disease
Patients with a history of transient ischemic attack (TIA) or stroke
Patients with recent signs or symptoms of myocardial ischemia
Intolerance to study medications
pre-existing contraindication to regional anesthesia
Non-English speaking patients
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Total shoulder arthroplasty patients who are receiving surgery at the Hospital for Special Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Jacques T YaDeau, MD, PhD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19388618 | Background | Friedman DJ, Parnes NZ, Zimmer Z, Higgins LD, Warner JJ. Prevalence of cerebrovascular events during shoulder surgery and association with patient position. Orthopedics. 2009 Apr;32(4):orthosupersite.com/view.asp?rID=38058. | |
| 21857267 | Background | Yadeau JT, Casciano M, Liu SS, Edmonds CR, Gordon M, Stanton J, John R, Shaw PM, Wilfred SE, Stanton M. Stroke, regional anesthesia in the sitting position, and hypotension: a review of 4169 ambulatory surgery patients. Reg Anesth Pain Med. 2011 Sep-Oct;36(5):430-5. doi: 10.1097/AAP.0b013e318228d54e. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Near-infrared Spectroscopy | Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM) Casmed Fore-Sight Elite Non-invasive Cardiac Output Monitor (NICOM) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients that were enrolled and not excluded due to receiving an intra-operative endotracheal tube or missing data from the monitors or instruments used.
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| ID | Title | Description |
|---|---|---|
| BG000 | Near-infrared Spectroscopy | Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM) Casmed Fore-Sight Elite Non-invasive Cardiac Output Monitor (NICOM) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Cerebral Desaturation Events | The number of Cerebral Desaturation Events (CDE) that occured. CDE is defined as a reduction in cerebral tissue oxygen saturation of >20% from baseline that lasts for 90 seconds or longer. | Posted | Number | Number of CDE Incidences | Day of surgery |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Near-infrared Spectroscopy | Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM) Casmed Fore-Sight Elite Non-invasive Cardiac Output Monitor (NICOM) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jacques Yadeau | Hospital for Special Surgery, Anesthesiology | 2126061036 | Yadeauj@hss.edu |
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| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Device |
|
| Day of surgery |
| Stroke Volume (SV) | Stroke volume, the amount of blood pumped by the left ventricle of the heart with each contraction. Measured in milliliters. | Day of surgery |
| Mean Arterial Pressure (MAP) | mean arterial pressure and noninvasive blood pressure will be represented as a percentage of baseline after surgery. A lower percentage is a worse outcome. | Day of surgery |
| End Tidal Carbon Dioxide (ETCO2) | a lower score is a better outcome. | Day of surgery |
| Intravenous Fluid Volume | Day of surgery |
| 21866430 | Background | Yadeau JT, Liu SS, Bang H, Shaw PM, Wilfred SE, Shetty T, Gordon M. Cerebral oximetry desaturation during shoulder surgery performed in a sitting position under regional anesthesia. Can J Anaesth. 2011 Nov;58(11):986-92. doi: 10.1007/s12630-011-9574-7. Epub 2011 Aug 25. |
| 23571083 | Background | Koh JL, Levin SD, Chehab EL, Murphy GS. Neer Award 2012: cerebral oxygenation in the beach chair position: a prospective study on the effect of general anesthesia compared with regional anesthesia and sedation. J Shoulder Elbow Surg. 2013 Oct;22(10):1325-31. doi: 10.1016/j.jse.2013.01.035. Epub 2013 Apr 6. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Cardiac Output (CO) | Cardiac output of patients as measured in liters per minute | Posted | Mean | Standard Deviation | liters per minute | Day of surgery |
|
|
|
| Secondary | Cardiac Index (CI) | Average cardiac index for patients, a measurement of how efficient the heart is pumping. Measured in liters per minute per meters squared of heart size. | Posted | Mean | Standard Deviation | L/min/m^2 | Day of surgery |
|
|
|
| Secondary | Stroke Volume (SV) | Stroke volume, the amount of blood pumped by the left ventricle of the heart with each contraction. Measured in milliliters. | Posted | Mean | Standard Deviation | milliliters | Day of surgery |
|
|
|
| Secondary | Mean Arterial Pressure (MAP) | mean arterial pressure and noninvasive blood pressure will be represented as a percentage of baseline after surgery. A lower percentage is a worse outcome. | Posted | Mean | Standard Deviation | percent | Day of surgery |
|
|
|
| Secondary | End Tidal Carbon Dioxide (ETCO2) | a lower score is a better outcome. | Posted | Mean | Standard Deviation | mmHg | Day of surgery |
|
|
|
| Secondary | Intravenous Fluid Volume | Posted | Mean | Standard Deviation | mL | Day of surgery |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |